PacePath Model 810
by Pacesetter Systems 510(k)
Active
510(k) K801416
Overview
The PacePath Model 810 is a Permanent Pacemaker Electrode, designed to interface with cardiac pacing systems for the treatment of bradycardia or other cardiac conduction disorders. This device delivers electrical impulses to stimulate the heart muscle, ensuring proper rhythm when the natural pacemaker fails to function adequately.
This electrode is intended for single-use implantation in cardiac procedures, supplied sterile and intended for use in clinical settings by trained medical professionals. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and was granted FDA 510K clearance under the Traditional pathway. Multiple registration numbers (e.g., 2017865, 3002618605) reflect its distribution and compliance tracking.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801416 | Date31 Oct 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What is the PacePath Model 810 used for in clinical practice?
The PacePath Model 810 is a permanent pacemaker electrode designed to interface with cardiac pacing systems. It delivers electrical impulses to stimulate the heart muscle, ensuring proper heart rhythm when the natural pacemaker fails—primarily for treating bradycardia or cardiac conduction disorders. It is intended for single-use implantation during cardiac procedures by trained medical professionals.
Is the PacePath Model 810 sterile and meant for reuse?
No, the PacePath Model 810 is supplied sterile and explicitly intended for single-use implantation only. It is not designed for reuse, as single-use electrodes are standard practice in cardiac pacing to maintain sterility and patient safety.
How is the regulatory approval status of this device?
The PacePath Model 810 received FDA 510(k) clearance under the Traditional pathway, with a substantially equivalent (SESE) determination. It is classified as a Class III medical device under 21 CFR 870.3680, reflecting its role in life-sustaining or supporting cardiac function.
What types of cardiac procedures is this electrode compatible with?
While the device description does not specify exact procedural details, the PacePath Model 810 is designed for permanent pacemaker implantation in patients with bradycardia or conduction disorders. It is intended for use in clinical settings by trained professionals, typically during electrophysiology or cardiac surgery procedures where a permanent pacing system is required.